Regulatory Services
At Russell Regulatory, our expert consultants specialise in offering services related to medical device regulation.
We also offer training for CE marking, UKCA marking, post market surveillance, clinical evaluation and risk management. It’s essential to be certain that you and your team are making decisions that adhere to legislation and won’t compromise patient safety. Our training packages are always bespoke and specific to your needs.
Here’s a glimpse into some of the services we offer.
A Regulatory Strategy can help you bring a new device to market, implement changes or plan certification in new regions. This saves your company time and helps forward-plan for future projects.
In addition to strategic advice, we also:
- Offer advice for device classification, helping to determine what classification your device falls under for UK, EU and US markets, avoiding problems with incorrect documentation
- Offer guidance around the FDA, providing support for companies who are launching a medical device in the USA
- Help your device achieve UKCA and CE Marking. Whether you’re launching your device in the UK or the European Union, we can help you bring it to market
Russell Regulatory can help with preparing technical files and GAP analysis to demonstrate the safety and performance of your device.
This is mandatory documentation for all types of medical devices, and we can help make it clearly prepared, impeccably organised and readily-searchable.
In addition to the above, we can also:
- Select Notified and Approved Bodies, showing you which bodies offer CE or UKCA marking, as well as which ones have capacity to take on new clients
- Determine testing requirements for your device, advising appropriate safety and performance standards to apply to your specific device type.
- Help to write the associated protocols and reports
- Help you select a test house. Not sure who to go to for independent testing such as biocompatibility? We at Russell Regulatory have relationships with a variety test houses and can help you pick the most appropriate one